# K120326: AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Nov 21, 2012 after 293 days
- Product code: JHX (Fluorometric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961828 (1996). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962549: Vidas Creatine Kinase MB Assay 30-421, Biomerieux Vitek, Inc. (1996) Summary page 2.
- K042924: Architect Stat Myo Immunoassay, Fisher Diagnostics (2005) Summary page 9.
- K050537: Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus, Bio-Rad (2005) Summary page 2.

## Most influential descendants
- K163462: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (2017), 0 descendants of its own

## Indications for use
AQT90 FLEX CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction. AQT90 FLEX CKMB CAL cartridge is for in vitro diagnostic use for the calibration of the CKMB Test on the AQT90 FLEX analyzer by establishing points of reference to estimate CKMB values. AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.

Source page: https://510kreport.com/device/K120326
Methodology: https://510kreport.com/methodology